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Trial record 1 of 1 for:    NCT02983370
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Development of a Cortical Visual Neuroprosthesis for the Blind (CORTIVIS)

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ClinicalTrials.gov Identifier: NCT02983370
Recruitment Status : Recruiting
First Posted : December 6, 2016
Last Update Posted : December 7, 2022
Hospital IMED Elche
Information provided by (Responsible Party):
Eduardo Fernandez, Universidad Miguel Hernandez de Elche

Brief Summary:
The objective of this study is to evaluate the usefulness of a cortical visual prosthesis based on intracortical microelectrodes to provide a limited but useful sense of vision to profoundly blind. This pilot study will provide important information on safety and efficacy for the development of an useful cortical visual neuroprosthesis for the blind.

Condition or disease Intervention/treatment Phase
Blindness Procedure: Minicraniotomy Not Applicable

Detailed Description:

Visual impairment is one of the ten most prevalent disabilities and poses extraordinary challenges to individuals in our society, which is heavily dependent on sight. Drug development and genetic engineering have had only marginal success as possible treatments but new hope has been generated by recent advances in neuroscience, micro-fabrication technologies, biomaterials, neuromorphic engineering and information and communication technologies leading to the development of highly sophisticated neural prosthetic devices which interact with the nervous system. Such assistive devices have already allowed thousands of deaf patients to hear sounds and acquire language abilities and the same hope exists in the field of visual rehabilitation.

Several research groups worldwide are engaged in attempts to restore vision through retinal prosthesis. However these devices are not viable for all causes of blindness. Thus, if the communication link between eye and brain is destroyed (e.g. for Glaucoma or optic nerve atrophy), as is the case for 148 million people worldwide, then visual cortical prosthesis holds the dominant hope for visual restoration. Consequently, there are many compelling reasons to pursue the development of a cortical prosthesis capable of restoring some useful vision in profoundly blind patients and this approach may be the only treatment available for end-stage retinitis pigmentosa patients and for pathologies such as glaucoma optic atrophy, trauma to the retina and/or optic nerves, and for diseases of the central visual pathways due to brain injuries or stroke.

The investigators will implant the CORTIVIS vision neuroprosthetic system, which utilizes a FDA cleared microelectrode array, into blind human volunteers and obtain descriptive feedback about visualized percepts. The experiments are designed to learn if volunteers can learn to integrate the electrical stimulation of brain visual areas into meaningful percepts. It is expected that a cortical device can create truly meaningful visual percepts that can be translated into functional gains such as the recognition, localization and grasping of objects or skillful navigation in familiar an unfamiliar environments resulting in a substantial improvement in the standard of living of blind and visually impaired persons.

All the experiments will be carried out at the patient's hospital room (Hospital IMED Elche) during the post-surgical period or in a human psychophysical laboratory (University Miguel Hernández).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pilot Study for the Development of a Cortical Visual Neuroprosthesis for the Blind Based on Intracortical Microelectrodes
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : May 2024

Arm Intervention/treatment
Experimental: Blind volunteer
Blind volunteers will be implanted with our existing vision neuroprosthetic system, which utilizes a FDA cleared microelectrode array, using a minicraniotomy. The array will be implanted near the occipital pole or in extra striate areas. The investigators will collect descriptive feedback regarding thresholds, evoked perceptions and stimulation parameters leading to recognizable patterns.
Procedure: Minicraniotomy
The surgical method for the implantation of the intracortical microelectrodes is straightforward and follows the standard neurosurgical procedures. Briefly, after the scalp is prepped with an antiseptic, a small skin incision is made. Then the skin and muscles are lifted off from the bone and folded back. Next, one small burr hole or a minicraniotomy of approximately 1.5 cm is made in the skull. This is a minimally invasive procedure that allows an easy access to the brain and is a standard procedure widely used in neurosurgery.

Primary Outcome Measures :
  1. Thresholds of visual perceptions elicited by intracortical microstimulation [ Time Frame: Within implantation period (up to 6 months) ]
    Charges needed for eliciting visual perceptions through electrical stimulation of the human cortex

Secondary Outcome Measures :
  1. Phosphene mapping [ Time Frame: Within implantation period (up to 6 months) ]
    Location of induced perceptions within the visual field by pointing with the finger where the phosphene is perceived

  2. Visual Acuity [ Time Frame: Within implantation period (up to 6 months) ]
    Spatial resolution measured by computerized visual tests

  3. Motion perception [ Time Frame: Within implantation period (up to 6 months) ]
    Correct perception of movement with a coarse pattern moving in one of four directions

  4. Visual function [ Time Frame: Within implantation period (up to 6 months) ]
    Effectiveness of intracortical microstimulation to recognize letters, habitual objects and complex stimulation patterrns as measured by a suite of visual function tests. Questionnaire.

  5. Number of participants with significant adverse events. [ Time Frame: Within implantation period (up to 6 months) ]
    Complications and adverse events will be assessed through participant description of any possible adverse event, neurological examination, clinical tests and a specific questionnaire.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Participant is capable and willing to provide informed consent for participation in the trial.
  • Severe visual impairment with bilateral visual loss.
  • Greater than 18 years of age.
  • General health: excellent.
  • Following a general physical and neurological examination, patient must have normal serum electrolytes, C-reactive protein, complete blood count and PT and PTT.
  • No history of stroke, seizure, coagulopathy, cardiac arrhythmias or ischemia, pulmonary, hepatic or renal disease, nor transmissible viruses such as hepatitis or HIV.
  • Stable dose of current regular medication for at least four weeks prior to trial entry.
  • Able to perform the study during the full time period of up to 6 months.

Special consideration will be given to patients with (1) detailed medical histories, including documentation of the onset, mechanism and evolution of the blindness; (2) lower risks associated with surgery; and (3) no psychiatric disorders or other mental disabilities.

Exclusion Criteria:

  • Age <18 or >70.
  • Period of appropriate visual functions < 12 years /lifetime.
  • For medical reasons: Individuals with a history of seizure disorders, coagulopathy, cardiac arrythmias or ischemia, pulmonary, hepatic or renal disease, and any other neurological disorder. Patients who carry a transmissible virus such as hepatitis and individuals with HIV-related neuropathies.
  • Vulnerable subject groups (e.g., pregnant women, prisoners, etc.).
  • Persons unable to give written informed consent prior to participation in the study.
  • Not able to perform the study during the full time period (at least 3 months).
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02983370

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Contact: Eduardo Fernandez, MD and PhD +34 965222001 e.fernandez@umh.es

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Hospital IMED Elche Recruiting
Elche, Alicante, Spain, 03202
Contact: Eduardo Fernandez, MD and PhD    +34965222001    e.fernandez@umh.es   
Universidad Miguel Hernandez de Elche Recruiting
Elche, Alicante, Spain, 03202
Contact: Eduardo Fernandez, MD and PhD    +34 965222001    e.fernandez@umh.es   
Sponsors and Collaborators
Universidad Miguel Hernandez de Elche
Hospital IMED Elche
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Principal Investigator: Eduardo Fernandez, MD and PhD Universidad Miguel Hernandez de Elche

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Responsible Party: Eduardo Fernandez, MD and PhD, Universidad Miguel Hernandez de Elche
ClinicalTrials.gov Identifier: NCT02983370    
Other Study ID Numbers: CORTIVIS16-HUM1
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: December 7, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases